SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Condition(s) studied
Investigational drug(s) / intervention(s)
SakuraBead Resorbable Microspheres: Temporary Embolization of Genicular Arteries using SakuraBead Resorbable Microspheres
Corticosteroid Injection: Corticosteroid injection in the knee
Study summary
An open label, prospective, two-arm, multicenter, randomized controlled trial comparing SakuraBead genicular artery embolization (GAE) with a control (corticosteroid injection).
Eligibility
Primary outcome measure(s)
- Primary Efficacy Endpoint - Proportion of Responders — 6 Months
Compare the proportion of responders\* (defined as ≥50% reduction in WOMAC Pain\*\* score and ≥2 point reduction in NRS\*\*\*) between the Investigational procedure and Control at 6 months. * Non-responders will include subjects experiencing device-related SAEs. \*\*Western Ontario and McMaster Universities Osteoarthritis Pain Index. Scale: 0-20, where a lower score represents a better outcome \*\*\*NRS: Numeric Rating Scale that measures pain from 0 (no pain) to 10 points (worst pain). - Primary Safety Endpoint - Freedom from treatment-related SAEs — 6 Months
Freedom from treatment-related serious adverse events (SAE) through 6 months following the index procedure (proportions will be compared between Investigational procedure and Control).
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama Medicine | Birmingham | Alabama | |
| Harbor UCLA Medical Center | Torrance | California | |
| Advanced Vascular Institute | Panama City | Florida | |
| IR Centers | Raleigh | North Carolina | |
| IR Centers | Leesburg | Virginia | |
| Bokhua Memorial Cardiovascular Center | Tbilisi | Georgia | |
| Royal Berkshire NHS Foundation Trust | Reading | United Kingdom | |
| Nano Medical Clinic | Tashkent | Uzbekistan |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06550024 on ClinicalTrials.gov ↗ ← All trials in the UK